Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months
This study is currently recruiting participants.
Verified March 2013 by Holdsworth House Medical Practice
Sponsor:
Holdsworth House Medical Practice
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier:
NCT01436136
First received: September 14, 2011
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
This is a cohort study which follows two groups of participants over a 12 months period. One group will access a team approach to care with the aim of reducing their cardiovascular disease (CVD) risks from a team of doctors, nurses and health care professionals. The other group will continue to access standard care from their treating doctor. Both groups will have CVD risk score evaluated after a 12 month period.
The team care approach will involve specific tests to measure CVD risk as well as smoking cessation, exercise and dietary advice and support, including monitoring such as blood pressure and cholesterol levels
| Condition | Intervention |
|---|---|
|
HIV-1 Infection Cardiovascular Disease |
Other: Control Other: Intervention Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effectiveness of Team Intervention Over 12 Months in Reducing Modifiable CVD Risk Factors on Framingham 10yr Risk Scores Outcomes in HIV-1 Subjects on Antiretroviral Therapy |
Resource links provided by NLM:
Further study details as provided by Holdsworth House Medical Practice:
Primary Outcome Measures:
- The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52. [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Intervention group
Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
|
Other: Control
GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
|
|
Active Comparator: Usual care (control) group
Within the context of an open, cohort study, GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
|
Other: Intervention Group
Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
intervention study intervention arm
Inclusion criteria:
- Documented HIV-1 infection
- Age 50 years or older
- Stable on ART ≥ 3/12
- Undetectable plasma HIV RNA (< 50 copies/ml)
- Moderate or high Framingham CVD risk score
- Life expectancy > 12 months
- Regular patient under care of non-director physician
- Willing to adhere to pharmacological CVD risk reduction intervention
- Willing to participate in lifestyle change advice intervention
Exclusion criteria for intervention study
- Life expectancy < 1yr
- Unable to undertake exercise
- Drug dependency
- Cognitive impairment affecting ability to participate in study
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mI U/ml)
- Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study
Inclusion criteria for intervention study control arm (Group 2)
- Documented HIV-1 infection
- Age 50 years or older
- Stable on ART ≥3/12
- Undetectable plasma HIV RNA (<50 copies/ml)
- Moderate or high Framingham risk score (>10%)
- Life expectancy > 12 months
- Regular patient under care of non-director physician
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436136
Contacts
| Contact: Mark T Bloch, MBBS | +61 02 9331 7228 | mark.bloch@holdsworthhouse.com.au |
| Contact: Avindra E Jayewardene | +61 02 9331 7228 | avindra.jayewardene@holdsworthhouse.com.au |
Locations
| Australia, New South Wales | |
| Holdsworth House Medical Practice | Recruiting |
| Sydney, New South Wales, Australia, 2010 | |
| Contact: Mark T Bloch, MBBS +61 02 9331 7228 Mark.Bloch@holdsworthhouse.com.au | |
| Contact: Trina M Vincent, RN +61 02 9331 7228 Trina.Vincent@holdsworthhouse.com.au | |
| Principal Investigator: Mark T Bloch, MBBS | |
Sponsors and Collaborators
Holdsworth House Medical Practice
Investigators
| Principal Investigator: | Mark T Bloch | Australian Health Practitioner Regulation Agency |
More Information
No publications provided
| Responsible Party: | Dr. Mark Bloch, Doctor, Holdsworth House Medical Practice |
| ClinicalTrials.gov Identifier: | NCT01436136 History of Changes |
| Other Study ID Numbers: | Reducing CVD risk in HIV |
| Study First Received: | September 14, 2011 |
| Last Updated: | March 18, 2013 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Holdsworth House Medical Practice:
|
Cardiovascular disease HIV Antiretroviral treatment team interventions Framingham risk score |
Additional relevant MeSH terms:
|
Cardiovascular Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013